Vaccine Therapy in Treating Patients With Metastatic Melanoma
This trial is active, not recruiting.
|Treatments||filgrastim, therapeutic autologous dendritic cells|
|Sponsor||Baylor Health Care System|
|Collaborator||National Cancer Institute (NCI)|
|Start date||April 2001|
|Trial identifier||NCT00017355, BAYUMC-000048, CDR0000068680, NCI-4170|
RATIONALE: Vaccines made from a patient's white blood cells mixed with tumor antigens may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.
Male or female participants at least 21 years old.
DISEASE CHARACTERISTICS: - Histologically confirmed metastatic melanoma - HLA-A2-01 phenotype - Measurable disease - No active CNS or hepatic metastases PATIENT CHARACTERISTICS: Age: - 21 and over Performance status: - Karnofsky 80-100% Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - See Disease Characteristics - No viral hepatitis Renal: - Not specified Cardiovascular: - No prior venous thrombosis, angina pectoris, or congestive heart failure - Lactate dehydrogenase less than 2 times normal Pulmonary: - No prior asthma Immunologic: - Intradermal skin test positivity to mumps, Candida, or streptokinase antigen - No known sensitivity to E. coli drug preparations - No prior allergy to influenza vaccine - No active infection - No prior autoimmune disease (e.g., lupus erythematosus, rheumatoid arthritis, or thyroiditis) Other: - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 8 weeks since prior interleukin-2 - At least 4 weeks since prior interferon alfa Chemotherapy: - At least 8 weeks since prior chemotherapy Endocrine therapy: - At least 2 weeks since prior corticosteroids - No concurrent corticosteroids Radiotherapy: - Not specified Surgery: - Not specified Other: - No concurrent immunosuppressive agents - At least 2 weeks since prior immunosuppressive agents
|Official title||Mature Dendritic Cell Immunotherapy Of Metastatic Melanoma- A Phase I Trial|
|Description||OBJECTIVES: - Determine the safety and tolerability of antigen-pulsed dendritic cell vaccine in patients with metastatic melanoma. - Determine the longevity of melanoma-specific immunity in patients treated with this regimen. - Perform serial analysis of T-cell and B-cell function in patients treated with this regimen. OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily on days 1-6 or 1-7. Patients undergo apheresis on days 6 and 7 or 6-8 to obtain peripheral blood mononuclear cells (PBMC). PBMC are processed for CD34+ cell isolation. These autologous CD34+ hematopoietic progenitor cells are cultured to generate dendritic cells (DC). DC are then pulsed with endotoxin-free keyhole limpet hemocyanin and HLA-A2-01 restricted flu-matrix peptides derived from melanoma-associated tumor antigens (MART-1:27-35, gp100:209-217, and MAGE-3). Antigen-pulsed DC are incubated with interferon alfa to induce DC maturation. Patients receive priming injections of antigen-pulsed DC vaccine SC once every 2 weeks for 8 weeks. Treatment repeats at 2, 3, 4, and 5 months after the last priming injection in the absence of unacceptable toxicity or disease progression. Patients are followed at 2 and 4 weeks and then every 3 months for 1.5 years. PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.|
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